NCT06575361Completed
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are: Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists. Participants will: Receive combination of systematic biopsy and targeted biopsy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 365 (actual)
- First submitted
- 26 Aug 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Peking University First Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06575361
What you commit to
- Study type: Interventional
- Participants enrolled: 365
- From 1 Jan 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
- Patients received prior prostate biopsy.
Other
- The clinicopathological information and MRI data was unqualified or incomplete.
- Patients had contraindications to MRI or prostate biopsy.
- Patients were not in accordance with the indication of prostate biopsy.
Who the study is looking for
- The age of the patient is between 45 and 85.
- Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control.
- Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
- Patients had no history of prior prostate surgery or biopsy.
- The PSA of patients should be ≤20 ng/mL.
- The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month.
- Patients with complete clinical information.
Age in the registry: 45 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.